This clinical research study is designed to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System), an investigational device developed to treat wide neck, large or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall of a blood vessel in the brain. The bulge is caused by a weakening of the vessel wall. If left untreated, the bulge may continue to grow larger and ultimately the vessel may break open (rupture), resulting in serious bleeding into our around the brain. The information collected from this study will be used to evaluate how well patients do when treated with the Surpass System both immediately after treatment of an aneurysm and over a long period of time (5 years).

Percent of subjects with 100% occlusion of the aneurysm without clinically significant stenosis (defined as less than or equal to 50% stenosis) of the parent artery based on core lab evaluation of the 12 month follow up angiogram and without any subsequent treatment of the target aneurysm at the 12 month follow up visit.

Percent of subjects experiencing one or more serious adverse events through 12 months post-index procedure within the following two categories (as adjudicated by the Clinical Events Committee) - (1) proportion of subjects with new or worsening major ipsilateral stroke, and 2) proportion of subjects experiencing acute or subacute (< 6 weeks) thrombosis of the Surpass Implant.

The objective of this study is to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System) in the endovascular treatment of large or giant wide-necked intracranial aneurysms in internal carotid artery up to the terminus.

Device: Surpass Flow Diverter

Treatment of an intracranial aneurysm involves the placement of a specially designed metallic mesh tube in a vessel in the brain where an aneurysm is located. The device looks like a fishnet sock with both ends open. Each device is delivered through a small catheter (a long, flexible tube). The catheter containing the device is inserted and advanced into a vessel in the brain. The device is then placed in the brain vessel by releasing it from the catheter. Once the device is placed inside the brain vessel, it is intended to reinforce the area of the vessel that is weakened and bulging (the aneurysm), and to cause blood to flow down the vessel and away from the aneurysm. This procedure is called an endovascular aneurysm treatment because the device is delivered through the blood vessels.

Other Names:

Flow diverter

Endovascular aneurysm treatment

Surpass NeuroEndoGraft System

Detailed Description:

The objective of this study is to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System) in the endovascular treatment of large or giant wide-necked intracranial aneurysms in the internal carotid artery up to the terminus. The Surpass Flow Diverter is an intracranial implant designed to be placed in a parent artery so as to divert blood flow away from an aneurysm. Use of the Surpass System may be associated with a decrease in neurological death or ipsilateral stroke in patients with large or giant wide-neck aneurysms. In a given patient, the Surpass System will be deemed effective if treatment results in complete occlusion of their aneurysm without clinically significant stenosis of the parent artery at one year.

Eligibility

Ages Eligible for Study:

19 Years to 80 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subject understands the nature of the procedure and provides written informed consent

Subject is willing to return to the investigational site for all scheduled follow-up visits

Subject is 19 to 80 years of age

Subject has a single targeted intracranial aneurysm

Exclusion Criteria:

Pregnancy

Enrollment in another trial

Allergy or contraindication to aspirin, Clopidogrel/Plavix, heparin, local or general anesthesia

History of life threatening allergy to contrast dye

Known allergy to nickel, chromium cobalt, tungsten or platinum.

Major surgery within previous 30 days or planned in the next 120 days after enrollment date

Severe neurological deficit that renders the subject incapable of living independently

Dementia or psychiatric problem that prevents the patient from completing required follow up

Co-morbid conditions that may limit survival to less than one year

Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis, or a history of intracranial vasospasm not responsive to medical therapy

Subject with an intracranial mass, or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region

Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions

Subject has a serum creatinine level greater than 2.5mg/dL (within 7 days of procedure) which the investigator determines restricts the use of contrast agents

Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment date

Subject has a previous intracranial implant associated with the symptomatic distribution within the past 12 weeks prior to treatment date

Subject has other known serious concurrent medical conditions such as heart disease, pulmonary disease or uncontrolled diabetes

Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date

Subject with resistance to Clopidogrel

Subject has a non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716117